| CTRI Number |
CTRI/2025/02/080453 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Plantar Fascia Release by Self-Myofascial Release versus Instrument-Assisted Soft Tissue Mobilization on Hamstring Tightness, Back Flexibility, and Neck Flexibility in High Heel Wearers. |
|
Scientific Title of Study
|
Effect of Plantar Fascia Release by Self-Myofascial Release versus Instrument-Assisted Soft Tissue Mobilization on Hamstring Tightness, Lumbar Flexibility, and Cervical Flexibility in High Heel Wearers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savita Behal |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab,India.
Amritsar
PUNJAB
143001
India |
| Phone |
7009217959 |
| Fax |
|
| Email |
saavib76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Amritsar , Punjab, India ,Affiliated under UGC, PCI,BCI,COA,NCTE. |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.
Amritsar
PUNJAB
143005
India |
| Phone |
9815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savita Behal |
| Designation |
Masters of Physiotherapy Student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab,India.
Amritsar
PUNJAB
143001
India |
| Phone |
7009217959 |
| Fax |
|
| Email |
saavib76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev University, Amritsar-143005, Punjab,India. |
|
|
Primary Sponsor
|
| Name |
Savita Behal |
| Address |
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India. |
| Type of Sponsor |
Other [Physiotherapy ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Maman Paul |
AssistantProfessor,
Department Of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maman Paul |
Guru Nanak Dev University |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar-143005, Punjab, India.
Amritsar
PUNJAB |
9815459353
mamanpaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
High Heel Wearers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self-Myofascial Release (SMR), Instrument-Assisted Soft Tissue Mobilization (IASTM). |
No control group; a direct comparison is made between SMR and IASTM. |
| Intervention |
Self-Myofascial Release (SMR), Instrument-Assisted Soft Tissue Mobilization (IASTM). |
Self-Myofascial Release (SMR): A self-administered technique that involves applying sustained pressure using a tool (e.g., a tennis ball) to release muscle tightness and improve fascial mobility. Instrument-Assisted Soft Tissue Mobilization (IASTM): A manual therapy technique using specially designed tools to apply controlled microtrauma to soft tissues. This stimulates a localized inflammatory response, promoting tissue remodeling, breaking down adhesions, and improving fascial mobility.Duration of Intervention will be 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Female |
| Details |
Regular high heel wearers, defined as those who wear high heels for at least 5 hours per day, 3 times per week, for a minimum duration of 6 months, will be included. The heels must have a minimum height of 5 cm. Participants should be able to wear heels without experiencing heel or foot pain. Additionally, a BMI range of 18.5 to 24.9 will be considered to minimize the risk of musculoskeletal issues. Only participants with bilateral plantar fascia tightness will be included.
|
|
| ExclusionCriteria |
| Details |
1.History of lower limb injuries or surgeries.
2.Diagnosed neuromuscular or skeletal conditions (e.g., scoliosis, disc herniation)
3.Known allergies or sensitivity to IASTM tools.
4.Positive Windlass Test (indicative of plantar fasciitis)
5.Morning heel pain upon standing.
6.Heel pain after prolonged sitting, resolving after 30-45 minutes of activity.
7.Significant foot arch deformities (flat feet or high arches)
8.History of foot trauma (e.g., calcaneal fractures, soft tissue injuries)
9.Psychological disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hamstring Tightness
2.Lumbar Flexibility
3.Cervical Flexibility |
Outcome Variable will be assessed baseline and after 6 weeks for both intervention groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study titled "Effect of Plantar Fascia Release by Self-Myofascial Release versus Instrument-Assisted Soft Tissue Mobilization on Hamstring Tightness, Lumbar Flexibility, and Cervical Flexibility in High Heel Wearers" focuses on participants aged 18–27 years who regularly wear high heels. This experimental study will recruit 60 participants, divided into two groups: Group A (Self-Myofascial Release and Static Stretching) and Group B (Instrument-Assisted Soft Tissue Mobilization and Static Stretching).The interventions will be administered three times a week over six weeks, targeting parameters such as cervical flexibility (assessed using the craniovertebral angle), lumbar flexibility (evaluated with the modified schober test and toe touch), and hamstring tightness (measured via the popliteal angle). Outcomes will be assessed pre- and post-intervention using standardized tools like Kinovea software for angle measurements and validated questionnaires to evaluate participants.This study aims to explore the biomechanical impact of high heels on the musculoskeletal system and to compare the efficacy of two therapeutic techniques in addressing musculoskeletal issues commonly associated with high heel use. |